ICOPE INTENSE-K Pilot Study

Toulouse University Hospital

Status: Enrolling

Conditions: Ageing

Treatments: Dietary Supplement: OMega 3; Dietary Supplement: vitamin B9; Other: ICOPE Step 1; Dietary Supplement: Vitamin B12; Other: ICOPE intense intervention; Dietary Supplement: Vitamin D3; Dietary Supplement: Leucin-rich whey; Dietary Supplement: Ketone Ester (KE) supplementation; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07048860

2025-A00891-48 (Other Identifier)

RC31/24/0519

Details and patient eligibility

About

ICOPE could constitute the reference model of care for healthy aging. More specifically, our hypothesis is that the intervention implemented in ICOPE may directly or indirectly prevent immuno-senescence, the loss of mobility and the cognitive decline. In future Geroscience clinical trials, ICOPE-Intense could become a benchmark to reduce the rate of aging with a strong non-pharmacological intervention and state a reference intervention to compare with new gerotherapeutic drugs.

Full description

In this pilot study, the concept of prevention proposed by the WHO, for everyday life is taken to the extreme to be able to judge what is the maximum effect size on key functions of aging (mobility, cognition, immunity) that can be expected and achieved by a nonpharmacological intervention. The results obtained will constitute reference data for the future, during the investigation on new gerotherapeutic drugs or other nonpharmacological interventions. Taking into account the hypothesis of a synergistic effect between Ketones and non-pharmacological intervention, the intense ICOPE program makes it possible to study the effect size of Ketones under optimal experimental conditions.

Enrollment: 40 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Independent-living (ADL ≥5/6)
• Men and women
• Mobility impairment (5 Chair-rise test >12 seconds)
• Sedentarism (spend six or more hours per day sitting or lying down)
• Positive screening for cognitive impairment according to the ICOPE screening tool with MMSE [25-28]
• BMI ≥25 kg/m2

Exclusion criteria

• Unintentional weight loss (≥10%) in past 6 months
• Dementia
• Life-threatening illnesses, with a life expectancy (judged by the investigating doctor) of less than 1 year
• Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina or any other contraindication to physical activity (as determined by a physician) or comorbid disease that would impair ability to participate in the ICOPE intense intervention such as renal failure on hemodialysis, severe psychiatric disorder (depressive participant will not be excluded)
• Organizational inability (three-time per week during the 60 days)
• Living in a Nursing-Home
• Under legal protection measure (guardianship, curatorship, safeguard of justice

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups, including a placebo group

ICOPE-intense group

Experimental group

Description:

ICOPE intense intervention + placebo

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Leucin-rich whey

Dietary Supplement: Vitamin D3

Dietary Supplement: Vitamin B12

Other: ICOPE intense intervention

Dietary Supplement: vitamin B9

Dietary Supplement: OMega 3

The ICOPE-intense + Ketone Ester (KE) group

Experimental group

Description:

ICOPE intense intervention + nutritional ketone esther suplementation

Treatment:

Dietary Supplement: Ketone Ester (KE) supplementation

Dietary Supplement: Leucin-rich whey

Dietary Supplement: Vitamin D3

Dietary Supplement: Vitamin B12

Other: ICOPE intense intervention

Dietary Supplement: vitamin B9

Dietary Supplement: OMega 3

The Ketone group

Experimental group

Description:

Usual ICOPE step 1 + ketone esther supplementation

Treatment:

Dietary Supplement: Ketone Ester (KE) supplementation

Other: ICOPE Step 1

Control group

Placebo Comparator group

Description:

Usual ICOPE step 1 + placebo

Treatment:

Dietary Supplement: Placebo

Other: ICOPE Step 1